In the intensive care units of hospitals (ICU), the patients often have thin water-like stools, which may be very aggressive to the perianal skin. For management of stools, diapers, faecal collecting bags or anal invasive products are used. The diapers often result in damaged skin and require frequent change and the invasive products are expensive. Collecting bags attached to the perianal skin is an attractive solution, but the devices on the market today have problems with a high degree of leakage.
U.S. Pat. No. 4,445,898 having Hollister Inc. as assignee describe a faecal incontinence device where an adhesive ring formed construction is used to attach a collecting device to the perianal area.
The company Hollister Inc. have products on the market, which consist of a collecting device with an adhesive construction designed for adhering to the perianal skin. One of the products comprises a 2 mm paste like adhesive with a foam-like backing welded to an open bag. The adhesive construction is circular (Φ110 mm) and has a 35 mm hole placed at a distance for the center of the adhesive construction. Before use a strip of release liner is removed from the adhesive surface and the adhesive construction is bend so that adhesive surface may be placed between the buttocks and on the perianal skin. Another product comprises a more elastic adhesive on a non-woven backing.
It has been found that by using a layered adhesive construction with a mouldable paste, e.g. a mouldable hydrocolloid adhesive, wrapped in one or more wrapping layers and having a skin friendly adhesive on the skin contact surface, provides a good leak resistant construction which may be shaped to fit folded or irregular skin surfaces. The adhesive construction of the invention is particularly useful for attaching collecting bags or collecting devices to the perianal area or around an ostomy.
Adhesive constructions comprising layers of hydrocolloid adhesives are well known in the art:
EP 1 527 789 A1 describes a construction comprising a film layer and at least two layers of hydrocolloid adhesives with different composition.
The prime object of the adhesive construction described therein is to provide a multi-layered adhesive medical appliance that has the attributes of a skin friendly wet tack pressure sensitive adhesive for use adjacent to the skin, and a flexible, comfortable, moisture tolerant adhesive that resists degradation after sterilization, and is capable of creating a seal around the stoma in a controlled fashion, for use away from the skin.
It is described that a disadvantage of the known skin-friendly adhesives used adjacent to the skin is that they tend to be somewhat rigid when they become too thick. Thus according to this application, it is preferred that the adhesive layer adjacent to the skin is thinner than the more flexible, comfortable, moisture tolerant adhesive, which is used away from the skin.
EP 1 527 789 A1 also describes that one of the adhesive layers may be of a mouldable hydrocolloid adhesive, and the mouldable adhesive layer in the construction is the one of the two adhesive layers placed between the skin contact adhesive and the film backing.
The adhesive construction according to the invention differ from the adhesive construction in EP 1 527 789 in that the mouldable paste is completely enveloped or enclosed in one or more wrapping layers, thereby preventing the mouldable paste from flowing out on the skin and leaving residues of the mouldable paste on the skin of patients.
EP 686 381 describes similar adhesive constructions with two layers of hydrocolloid adhesives with different composition. According to this patent application, the layer of adhesive securing the adhesive construction to the skin is composed of a skin friendly hydrocolloid containing adhesive that has a relatively low resistance to dissolution and/or disintegration when contacted by stomal fluids, whereas the other adhesive layer placed away from the skin is composed of a relatively soft, easy-deformable and extrudable adhesive sealant material that is more resistant to dissolution or disintegration by stomal fluids than the material of the skin contact adhesive. From the drawings it is clear that the adhesive layer adjacent to the skin is thinner than the adhesive layer placed away from the skin.
The adhesive construction according to the invention differ from the adhesive construction according to EP 686 381 in that the mouldable paste is completely wrapped in one or more wrapping layers, thereby preventing the mouldable mass from flowing out on the skin and leaving residues of the mouldable paste on the skin of patients.
WO 98/17212 relates to a separate sealing member for use in connection with ostomy appliances. The separate sealing member may be in the form of a mouldable ring or paste of a hypo-allergenic adhesive, which during use is placed in the hole of the wafer of an ostomy appliance to seal around the stoma. FIGS. 7 and 8 relates to a particular embodiment where the sealing member is in the form of a mouldable ring with a core of soft, easy deformable, non-memory putty like material wrapped in a thin, flexible wrapping material. The wrapping material may be a water permeable membrane coated with a skin friendly adhesive on the outside or the wrapping material may itself be a skin friendly hydrocolloid-containing barrier adhesive.
It is described that the wrapping material improves the performance of the mouldable ring due to the elimination of the risk of dissolution of the deformable core material and the elimination of the risk that residues of the core material is left on the skin after removal of the sealing member.
It has now been found that a layered adhesive construction comprising a layer of a mouldable paste wrapped in one or more wrapping layers, and comprising a first adhesive layer attached to the wrapping layer on one outer surface of said layer of mouldable paste wrapped in wrapping layer(s) is particularly useful for attaching collecting bags or collecting devices to the perianal skin.
The adhesive construction according to the invention differs from the adhesive construction described in WO 98/17212 in that the construction only has an adhesive on one of its outer surfaces and in that it has areas where the mouldable paste is absent. Furthermore, the adhesive construction of the invention preferably has a hole going through the construction, which hole is not place in the center of the construction but in one end of the construction. This position of the hole is an advantage when the adhesive construction is used to attach a collecting bag or collecting device to the perianal area, where the distance from the anus to the vagina respectively the scrotum, sets some limits with regard to the perianal area available for attaching the device.